MPS 3 Delivery Set w/AA w/305cm Line (16C)

GUDID 20634624516315

QUEST MEDICAL INC

Cardioplegia solution administration kit
Primary Device ID20634624516315
NIH Device Record Key43219e8d-f14c-4f98-adc4-53dae4f252d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMPS 3 Delivery Set w/AA w/305cm Line (16C)
Version Model Number5163102
Company DUNS041810693
Company NameQUEST MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com
Phone1-800-627-0226
Emailcustserv@questmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100634624516311 [Primary]
GS120634624516315 [Package]
Contains: 00634624516311
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWCController, Temperature, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-04
Device Publish Date2020-07-27

Devices Manufactured by QUEST MEDICAL INC

20634624530380 - MPS 3 ISO Medical Air Hose Kit2023-10-24
20634624530397 - MPS 3 Drug Pump Cover2023-04-03
20634624101153 - Q2 IV Administration Set2022-12-14
20634624101252 - Q2 IV Administration Set2022-12-14
20634624101306 - Q2 IV Administration Set2022-12-14
20634624601257 - Q2 IV Administration Set2022-12-14
20634624921096 - High-Flow 4-Way Stopcock2022-12-14
20634624921102 - High-Flow 4-Way Stopcock2022-12-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.